Skin GraftPhase 1NCT04664738
PEP on a Skin Graft Donor Site Wound
A Phase 1 study testing 10% PEP, TISSEEL and 20% PEP in people with Skin Graft, run by Rion Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to determine the safety of a biological therapeutic PEP in participants who have skin graft donor site wounds. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Skin Graft
- What is being tested?
- 10% PEP, TISSEEL and 20% PEP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Mar 2021to 2 Feb 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Criteria for Inclusion:
- Males and females 18-75 years of age.
- Requiring at least two 20-40 cm2 split-thickness skin grafts by a licensed surgeon or dermatologist
- Skin graft that meets all the following criteria:
- Each graft site has a size of 20-40 cm2 (but can be up to 90 cm2 if found to be clinically indicated during the graft procedure)
- Located anywhere on the body (with exception of oral mucosal membranes)
- Split-thickness skin graft wound depth of between 8/1000-14/1000 inch
- Study donor sites are ≥ 1 cm apart
- Ability to safely undergo skin graft harvest procedure
- Capacity to provide informed consent
- Ability to comply with protocol
- Subject is judged, by the clinical investigator, to be healthy as evidenced by lack of clinically significant abnormal findings on medical history, physical examination, vital signs, and clinical laboratory tests
- Subject is able and willing to return to study site for all follow-up visits
Main Criteria for Exclusion:
- Actively undergoing chemotherapy treatment (localized radiation treatment is allowed if it is not on the skin graft donor site and no active cancer is present)
- Known history of MRSA (methicillin-resistant Staphylococcus aureus)
- Known hypersensitivity to aprotinin (Trasylol®)
- Subjects who are positive for hepatitis B surface antigen (HbsAg), hepatitis C antibody or human immunodeficiency virus (HIV)
- Any known allergy or sensitivity to adhesive dressings (e.g., Tegaderm)
- Clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurological, psychiatric, immunological, gastrointestinal, hematological, or metabolic disease that is, in the opinion of the investigator, not stabilized or may otherwise impact the results of the study
- Participation in another interventional clinical study or trial in the past 30 days or concurrent participation in another interventional clinical study or trial
- Subjects with poorly controlled diabetes mellitus (Hemoglobin A1c [HbA1c] ≥ 8%)
- Subjects with known peripheral neuropathy, or known concomitant vascular problems (such as peripheral artery disease, arterial insufficiency, or venous hypertension) or calciphylaxis
- Subjects with burns covering ≥ 30% of Total Body Surface Area
- Currently on or planned to receive hyperbaric wound therapy
- Pregnant or lactating female subjects
- Sexually active woman of childbearing potential who is unwilling to use approved contraception method for 3 months after receiving dose of investigational drug
- Prisoners
Trial locations and contacts
2 sites in 1 country.
United States2 sites
International Research Partners
Doral, Florida, 33122
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Phase I Open-Label Trial to Determine the Safety of PEP on a Skin Graft Donor Site Wound
The purpose of this study is to determine the safety of a biological therapeutic PEP in participants who have skin graft donor site wounds.
Read the detailed description
This is an open label phase 1b study of PEP (a leukocyte depleted blood preparation derived from human U.S. sourced pooled apheresed platelets) in patients with at least two donor split-thickness skin graft wounds. One donor site will be treated with the standard post-operative dressing, while the other site will be treated with PEP or PEP+TISSEEL and covered with a standard dressing. TISSEEL is a commercially available fibrin sealant.
- Conditions
- Skin Graft
- Being tested
- 10% PEP, TISSEEL, 20% PEP
- Keywords
- skin graft, exosome, PEP, wound, healing
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10% PEPBiological
PEP is comprised of platelet derived extracellular vesicles enriched in anti-inflammatory and angiogenic growth factors.
TISSEELDrug
Also called fibrin sealant
Fibrin sealant made from pooled human plasma
20% PEPBiological
PEP is comprised of platelet derived extracellular vesicles enriched in anti-inflammatory and angiogenic growth factors.
| Study group | Role | What they receive |
|---|---|---|
| 10 % PEP only | Experimental | Cohort 1: Subjects will receive 10% PEP to the skin graft donor wound. Receives: Biological: 10% PEP |
| 20% PEP only | Experimental | Cohort 2: Subjects will receive 20% PEP to the skin graft donor wound Receives: Biological: 20% PEP |
| 20% PEP and TISSEEL | Experimental | Cohort 3: Subjects will receive 20% PEP and TISSEEL to the skin graft donor wound. Receives: Drug: TISSEEL; Biological: 20% PEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute dose limiting toxicities (DLTs) of PEP / PEP-Tisseel
The primary endpoint is to determine the acute (within first 14 days) safety and tolerability of PEP or PEP-TISSEEL, as assessed by the occurrence of DLTs on a 20-40 cm2 (but can be up to 90 cm2 if found to be clinically indicated during the graft procedure) skin graft donor site wound at escalating concentrations of PEP delivered at one time point through the 14-day DLT period.
Measured: Up to 2 weeks (within the first 14 days) for each dosing cohort
Maximum Tolerated Dose (MTD) of PEP / PEP-Tisseel
The endpoint is to determine the acute (within first 14 days) safety and tolerability of PEP or PEP-TISSEEL, as assessed by the occurrence of MTDs on a 20-40 cm2 (but can be up to 90 cm2 if found to be clinically indicated during the graft procedure) skin graft donor site wound at escalating concentrations of PEP delivered at one time point through the 14-day MTD period.
Measured: Up to 2 weeks (within the first 14 days) for each dosing cohort
Secondary outcomes (1)
Long Term safety of PEP / PEP-Tisseel
The secondary endpoint is to determine the safety and tolerability of a single dose of PEP or PEP-Tisseel delivered at a single time point, as assessed by the occurrence of DLTs through the Day 15-182 DLT period
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start16 Mar 2021
- Primary completion9 Aug 2023
- Study completion2 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin GraftStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rion Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ProPharma Group
- Responsible party
- Sponsor
- Investigators
- Michael Sabbah, MD, Study director, Rion Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664738
- Sponsor's protocol ID
- PRO-00068
- Other IDs
- 18-004995
- Status last verified
- Jun 2023
- First submitted
- 7 Dec 2020
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-Label Trial to Determine the Safety of PEP on a Skin Graft Donor Site Wound
- ClinicalTrials.gov ID
- NCT04664738
- Acronym / sponsor ID
- PRO-00068
- Conditions
- Skin Graft
- Keywords
- skin graft, exosome, PEP, wound, healing
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Rion Inc.Industry (pharma, biotech, devices)
- Collaborators
- ProPharma Group
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 9 Aug 2023 (actual)
- Study completion
- 2 Feb 2024 (estimated)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety of a biological therapeutic PEP in participants who have skin graft donor site wounds.
Detailed description
This is an open label phase 1b study of PEP (a leukocyte depleted blood preparation derived from human U.S. sourced pooled apheresed platelets) in patients with at least two donor split-thickness skin graft wounds. One donor site will be treated with the standard post-operative dressing, while the other site will be treated with PEP or PEP+TISSEEL and covered with a standard dressing. TISSEEL is a commercially available fibrin sealant.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 10 % PEP only | Experimental | Biological: 10% PEPCohort 1: Subjects will receive 10% PEP to the skin graft donor wound. |
| 20% PEP only | Experimental | Biological: 20% PEPCohort 2: Subjects will receive 20% PEP to the skin graft donor wound |
| 20% PEP and TISSEEL | Experimental | Drug: TISSEEL, Biological: 20% PEPCohort 3: Subjects will receive 20% PEP and TISSEEL to the skin graft donor wound. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10% PEPPEP is comprised of platelet derived extracellular vesicles enriched in anti-inflammatory and angiogenic growth factors. | Biological | 10 % PEP only |
| TISSEELAlso: fibrin sealantFibrin sealant made from pooled human plasma | Drug | 20% PEP and TISSEEL |
| 20% PEPPEP is comprised of platelet derived extracellular vesicles enriched in anti-inflammatory and angiogenic growth factors. | Biological | 20% PEP and TISSEEL, 20% PEP only |
Primary outcome
Acute dose limiting toxicities (DLTs) of PEP / PEP-Tisseel
Time frame: Up to 2 weeks (within the first 14 days) for each dosing cohort
The primary endpoint is to determine the acute (within first 14 days) safety and tolerability of PEP or PEP-TISSEEL, as assessed by the occurrence of DLTs on a 20-40 cm2 (but can be up to 90 cm2 if found to be clinically indicated during the graft procedure) skin graft donor site wound at escalating concentrations of PEP delivered at one time point through the 14-day DLT period.
Maximum Tolerated Dose (MTD) of PEP / PEP-Tisseel
Time frame: Up to 2 weeks (within the first 14 days) for each dosing cohort
The endpoint is to determine the acute (within first 14 days) safety and tolerability of PEP or PEP-TISSEEL, as assessed by the occurrence of MTDs on a 20-40 cm2 (but can be up to 90 cm2 if found to be clinically indicated during the graft procedure) skin graft donor site wound at escalating concentrations of PEP delivered at one time point through the 14-day MTD period.
1 secondary outcome
Long Term safety of PEP / PEP-Tisseel
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Rion company websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Sabbah, MD study director
Rion Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 10% PEP, TISSEEL and 20% PEP in people with Skin Graft, run by Rion Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute dose limiting toxicities (DLTs) of PEP / PEP-Tisseel (time frame: Up to 2 weeks (within the first 14 days) for each dosing cohort). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.